Periodontal Status and Thyroid Markers in Pregnancy

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-45
SponsorPostgraduate Institute of Dental Sciences Rohtak

About this trial

This cross-sectional study aims to evaluate the association between periodontal status and serum thyroid markers among 100 systemically healthy pregnant women aged 18-45 years in the second trimester (13-27 weeks). Pregnancy is characterized by profound hormonal and immunological changes that influence both periodontal health and thyroid function. While periodontal inflammation has been associated with thyroid dysfunction in the general population, no study has explored this relationship during pregnancy. Participants will be recruited from the Department of Gynaecology, PGIMS, Rohtak, and undergo comprehensive periodontal examination, including periodontal inflamed surface area (PISA), probing pocket depth (PPD), clinical attachment loss (CAL), bleeding on probing (BOP), and plaque index (PI). Blood samples will be collected to assess thyroid stimulating hormone (TSH), triiodothyronine (T3), thyroxine (T4), anti-thyroid peroxidase (Anti-TPO) antibodies, and high-sensitivity C-reactive protein (hsCRP). The primary objective is to determine the association between PISA and serum TSH levels, while secondary objectives include evaluating the relationship of periodontal parameters with T3, T4, Anti-TPO, hsCRP, and the distribution of thyroid profiles (euthyroid, hypothyroid, and hyperthyroid) according to periodontal status. Data will be analyzed using appropriate descriptive statistics, Pearson/Spearman correlation, and multiple linear regression after testing for normality. By investigating the interplay between periodontal inflammation and thyroid function during pregnancy, this study seeks to generate novel evidence that may support integrated periodontal and antenatal care strategies, ultimately contributing to improved maternal and fetal health outcomes.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Pregnant women aged 18-45 years

Singleton pregnancy

Gestational age between 13 and 27 weeks (second trimester)

Presence of ≥20 natural teeth (excluding third molars)

Disqualifiers

History of previously diagnosed thyroid disorders (diagnosed prior to pregnancy or currently)

Current use of thyroid-related medication

Presence of systemic diseases known to affect periodontal status or inflammatory response (e.g., diabetes mellitus, gestational diabetes mellitus, autoimmune diseases, cardiovascular disorders)

Use of antibiotics, anti-inflammatory drugs, corticosteroids, or immunosuppressive agents within the previous 3 months

Trial population

The study population will include systemically healthy females aged between 18- 45 years in second trimester of pregnancy attending out patient department of Department of Gynaecology, PGIMS, Rohtak for regular antenatal evaluation.

Trial design

Design model

Other

Time perspective

Cross-sectional

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

Thyroid Stimulating hormone

evaluation of thyroid stimulating hormone (TSH) and its corelation with clinical periodontal parameters : bleeding on probing (BOP), probing pocket depth (PPD) and clinical attachment loss (CAL), plaque index (PI) and periodontal inflamed surface area (PISA) among pregnant women in second trimester.

Time frame
baseline

Secondary outcomes

1

Thyroxine (T4)

Correlation of Thyroxine (T4) with periodontal probing depth \[PPD\], clinical attachment loss \[CAL\], bleeding on probing \[BOP\] and plaque index \[PI\] \] among pregnant women in second trimester.

Time frame
baseline
2

Triiodothyronine (T3)

Correlation of Triiodothyronine (T3) with periodontal probing depth \[PPD\], clinical attachment loss \[CAL\], bleeding on probing \[BOP\] and plaque index \[PI\] \] among pregnant women in second trimester.

Time frame
baseline
3

Anti-Thyroid Peroxidase Antibody [Anti- TPO]

Correlation of Anti-Thyroid Peroxidase Antibody \[Anti- TPO\] with periodontal probing depth \[PPD\], clinical attachment loss \[CAL\], bleeding on probing \[BOP\] and plaque index \[PI\] \] among pregnant women in second trimester.

Time frame
baseline
4

High Sensitivity C-Reactive Protein (hsCRP)

Correlation of High Sensitivity C-Reactive Protein (hsCRP) with periodontal probing depth \[PPD\], clinical attachment loss \[CAL\], bleeding on probing \[BOP\] and plaque index \[PI\] \] among pregnant women in second trimester.

Time frame
baseline

Other outcomes

Sponsors and contacts

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